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Efficacy and Safety Study of Intra-Articular Injections of Autologous Peripheral Blood Stem Cells Following Subchondral Drilling Surgery for the Treatment of Articular Cartilage Injury in the Knee

NCT03101163 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-16

No results posted yet for this study

Summary

This is a 24-month, multicenter, randomized, open-label, standard treatment-controlled, parallel-group, Phase 2 study for adults with large or complicated knee articular cartilage lesions and are candidates for knee joint cartilage repair surgery. The safety and efficacy of intra-articular injections of peripheral blood stem cells (PBSCs) together with hyaluronic acid (HA) after subchondral drilling surgery will be evaluated to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than a standard treatment (HA injections and physiotherapy regimen).

Conditions

  • Articular Cartilage Disorder of Knee
  • Articular Cartilage; Degeneration

Interventions

BIOLOGICAL

Autologous peripheral blood stem cells and hyaluronic acid

Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy

OTHER

Hyaluronic acid

Regimen of intra-articular HA injections and postoperative physiotherapy

Sponsors & Collaborators

  • KLSMC Stem Cells, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Drug
Yes

Countries

  • United States
  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03101163 on ClinicalTrials.gov